Dr. Mason’s Experience Relevant to Cardiac Safety Consultation

Relevant Experience

Jay W. Mason, MD

  • Investigator in Early Phase Development of several antiarrhythmic drugs (tocainide, encainide, flecainide, amiodarone, primenol, sotalol, acebutalol, N-acetylprocainamide, diltiazem, imipramine, and bethanidine) and devices (Intermedics antitachycardia device series, Intec AICD, Medtronic implantable hemodynamic monitor)

  • Principal Investigator of multinational, NIH-funded clinical trials (ESVEM – Electrophysiologic Study Vs. Electrocardiographic Monitoring; MTT – the US Myocarditis Treatment Trial; SCOR - Specialized Center of Research in sudden Death)

  • Data and Safety Monitoring Boards for NIH-funded clinical trials (Member, Digitalis Mortality Trial; Chair, Antiarrhythmic Effects of N-3 Fatty Acids; Chair, Fatty Acid Arrhythmia Trial; Member, Periodontal Intervention in Cardiac Events; Chair, Resuscitation Consortium; Member, ResQ Trial; Member VEST Trial)

  • Electrocardiography Standards Setting Committees- (Chair, ECG-Self Assessment Program, American College of Cardiology [ACC]; Chair, ACC ECG Exam; Member, ACC Electrocardiography/ Electrophysiology/Electrocardiography Committee; Member, American Heart Association Electrocardiography Standardization Committee; Publications - Co-author, Guidelines for clinical intracardiac electrophysiologic studies - A Report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures; Co-author, Guidelines for implantation of cardiac pacemakers and antiarrhythmia devices. A Report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures; Recommended guidelines for training in adult clinical cardiac electrophysiology. ACC Policy Statement; Author, American College of Cardiology Report on ECG Exam; Co-author, ACC/AHA clinical competence statement on electrocardiography and ambulatory electrocardiography; Author, AHA ECG Diagnostic Statement List)
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  • Sponsor Support at FDA Meetings  Multiple teleconference and face-to-face meeting with FDA on behalf of pharmaceutical companies since 1985
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  • Core ECG Laboratory Medical Director,Covance Cardiac Safety Service, 2003 – 2007; Chief Medical Officer, Spaulding Clinical Research; consultant to pharma sponsors on drug development strategy, clinical trial design, expert analysis of cardiac safety data and interaction with FDA

  • Medical Device Developer Co-founder of Kardiatec, S.A., a medical device company developing the PULVAD, a ventricular assist device based upon the principle of counterpulsation; Co-inventor, Spaulding Electrocardiograph